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510(k) K041378

BIO 60 by Kodent, Inc. — Product Code EJT

K041378 is an FDA 510(k) premarket notification submitted by Kodent, Inc. for the device "BIO 60". The FDA issued a decision of Substantially Equivalent on August 2, 2004. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2004
Date Received
May 24, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Gold-Based Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type

Other clearances for product code EJT

  • K052463 — PROMETAL HN86 (October 14, 2005)
  • K040672 — PORTA REFLEX (May 27, 2004)
  • K040524 — PORTA SOLDER 1090 W (May 20, 2004)
  • K040043 — NDX-40 ALLOY (March 3, 2004)
  • K034049 — HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, (March 1, 2004)
  • K033279 — GOLD DENTAL CASTING ALLOYS (January 15, 2004)
  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (November 13, 2003)
  • K033435 — E-SARANG 86, DM78, DM55 (November 12, 2003)
  • K032320 — APPOLLO 3 ALLOY (October 1, 2003)
  • K032319 — CERA R PLUS ALLOY (September 30, 2003)

FDA data resources